NCT Number: NCT07558018
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries). We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.
Trial opening soon.
Get Notified18 year–65 year
Female
Observational
The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC). The upper age limit was established to limit the influence of vascular senescence on the results.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigation of Systemic Endothelial Microvascular Function
Other names: Myocardial Perfusion Imaging, Sublingual videomicroscopy, Invasive coronary flow determination, Cutaneous Laser Speckle Contrast Imaging
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of systemic microvascular reactivity induced by endothelium-independent agent (sodium nitroprusside). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of systemic microvascular reactivity induced by postocclusive reactive hyperemia. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Sublingual microcirculatory density and perfusion will be assessed using a handheld camera based on incident dark-field (IDF) imaging.
Contact information is provided by the study sponsor or research team.
National Institute of Cardiology, Laranjeiras, Brazil
Other Gov
Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)
Acronym: NOCAWT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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